Proteus Digital Health – 2012 Fierce 15

The Scoop: After four years of working with regulators, Proteus Digital Health made history in late summer by gaining FDA de novo clearance for its Ingestion Event Marker, or ingestion sensor. Approval comes two years after the company won its CE mark for the broader technology platform. The sensor can be blended into an inert pill or other pharmaceutical that a patient swallows, after which a clinician gathers data it collects in order to form a patient treatment plan.

What Makes It Fierce: An ingestible sensor that can be blended with a pill? Simply put, this takes the standard of care possibilities to a whole new level. Since its launch in 2003, Proteus has raised more than $100 million in more than 6 funding rounds of venture capital, and through corporate partnerships with investors such as Medtronic ($MDT), Kaiser Permanente, Otsuka and Novartis ($NVS). The company also notes a $25 million funding round from June that remains open. What's unique about its technology is that it doesn't need a battery or antenna and is made entirely "from ingredients found in food," notes CEO Andy Thompson. In other words, the sensor is biodegradable, the size of a microscopic grain of sand and as he explains, it gives "each medicine an electrical signature just like a heart beat." Once swallowed, a clinician gathers data from what the sensor picks up in order to develop a treatment plan for the patient.

"We don't think there is anyone else in the world that can digitize a drug," Thompson says.

Proteus devoted some time to working with regulators to hash out approval standards and frameworks for a technology that is unprecedented in combining a device with a drug to improve treatment. It is designed to combine medicine with "information and social connectivity" in order to monitor patients and help them use their medicine correctly. Thompson says the drug represents an entirely new category, as it is combined with "information delivered by social media, and a cell phone already in your pocket." In short, stomach fluid triggers the ingestible sensor and it communicates a signal to a patch on the skin, which, as the company explains, records data including heart rate, body position and activity. That data, in turn, gets relayed to a mobile phone app, and with a patient's consent is accessed by clinicians and caregivers working to develop a care plan.

"It is fair to say we have been working with the [FDA] for some time," Thompson says, "and that the regulatory clearances and approvals we have received so far represent a substantial amount of work, not only to make sure the products and product components we want to get approved are approved on their own, but that the agency understands the direction we're headed."

Proteus describes its technology as working with three categories of products: lifestyle tools, caregiver solutions and digital control/digital components.

Thompson adds that Proteus is continuing discussions with the agency "on a number of different levels on how digital products can yield a substantial amount of value in health sustainability on a number of levels." In short, they have had to work with regulators to teach them about something with no precedent and to develop a framework that can ensure its safe use at the same time.

What To Look For: Proteus envisions a European launch of some products beginning in the next several weeks and through the remainder this year. Those will include use of the technology in areas such as elder care, with "folks eager to stay at home but struggling with the use of multiple medications in daily life and want help with that," Thompson says. "Our initial platform is focused on that demographic and providing families and family caregivers with tools that can help with those tasks." Products derived from these European initiatives will debut in the U.S. in 2013 and 2014, Thompson says, with "fully integrated digital medicines" starting in 2014, developed with development partners and also directly at Proteus.